Traumatic Brain InjuryNCT03000400
Family Centered Intervention After Traumatic Brain Injury
A study testing The Traumatic Brain Injury Family System Intervention. and Psycho-educational session at OUH in people with Traumatic Brain Injury, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- The Traumatic Brain Injury Family System Intervention. and Psycho-educational session at OUH
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2017to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should:
- Be out of post traumatic amnesia for at least one month
- Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
- Have a Ranchos Los Amigos Scale score of at least 8
- Mini Mental Status Examination score >23
- Family members: individuals related by blood or marriage/cohabitating with the TBI patient.
- Belongs to the same household as the individual with TBI and/or in close relation with the patient
- are between 18-65 years of age.
Who cannot join
- TBI survivors or their family members with a history of psychiatric or neurologic illness, active learning disability, or active substance abuse. Inability to speak and read Norwegian. Families in which there are other members requiring care or who have previously been caregivers for other family members.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Family as a Resource for Improving Patient and Family Functioning After Traumatic Brain Injury. A Randomized Controlled Trial of a Family Centered Intervention
The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. The intervention will be provided in collaboration with the municipal rehabilitation service. The intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by Oslo University Hospital (OUH).
- Conditions
- Traumatic Brain Injury
- Being tested
- The Traumatic Brain Injury Family System Intervention., Psycho-educational session at OUH
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Traumatic Brain Injury Family System Intervention.Behavioural
Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
Psycho-educational session at OUHBehavioural
2.5 hour psycho-educational session for the patient's family members.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention. Receives: Behavioral: The Traumatic Brain Injury Family System Intervention. |
| Control group | Active comparator | Family members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH). Receives: Behavioral: Psycho-educational session at OUH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
Mental health for all study participants
Measured: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Change in Caregiver Burden Scale (CBS)
Caregiver Burden for the family members
Measured: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Secondary outcomes (2)
Quality of Life after Traumatic Brain Injury (QOLIBRI)
Quality of Life for the patients
Measured: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Faces IV
Family dynamics for all study participants
Measured: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation, The National Association for the Traumatically Injured, Norway, Baerum municipality, Department of Rehablitation, Norway
- Responsible party
- Principal investigator, Helene Lundgaard Søberg, Oslo University Hospital
- Investigators
- Helene L. Soberg, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000400
- Sponsor's protocol ID
- 2016/1215/REK sør-øst C
- Status last verified
- Nov 2020
- First submitted
- 11 Nov 2016
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Family as a Resource for Improving Patient and Family Functioning After Traumatic Brain Injury. A Randomized Controlled Trial of a Family Centered Intervention
- ClinicalTrials.gov ID
- NCT03000400
- Acronym / sponsor ID
- 2016/1215/REK sør-øst C
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Norwegian Extra Foundation for Health and Rehabilitation, The National Association for the Traumatically Injured, Norway, Baerum municipality, Department of Rehablitation, Norway
- Study start
- Jan 2017 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 22 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of a multi-professional theoretically based family centered intervention, The Traumatic Brain Injury Family System Intervention (TBIFSI), for the family members and TBI patients in improving family dynamics and functioning. The intervention will be provided in collaboration with the municipal rehabilitation service. The intervention group will be compared with a control group receiving treatment as usual, defined as an individually tailored multidisciplinary approach, and the family members will attend one ongoing psycho-educational group session of 2.5 hour provided by Oslo University Hospital (OUH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: The Traumatic Brain Injury Family System Intervention.Patient and family members receiving the 8 week family centered intervention, The Traumatic Brain Injury Family System Intervention. |
| Control group | Active comparator | Behavioral: Psycho-educational session at OUHFamily members attend one ongoing psycho-educational group session provided by Oslo University Hospital (OUH). |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Patients: Home dwelling individuals age 16-65 who have sustained a TBI and receiving health services. They should:
- Be out of post traumatic amnesia for at least one month
- Have been discharged from post-acute rehabilitation in the specialized health care system in the last 6 - 18 months
- Have a Ranchos Los Amigos Scale score of at least 8
- Mini Mental Status Examination score >23
Key exclusion criteria (1 listed)
- TBI survivors or their family members with a history of psychiatric or neurologic illness, active learning disability, or active substance abuse. Inability to speak and read Norwegian. Families in which there are other members requiring care or who have previously been caregivers for other family members.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Traumatic Brain Injury Family System Intervention.Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual. | Behavioural | Intervention group |
| Psycho-educational session at OUH2.5 hour psycho-educational session for the patient's family members. | Behavioural | Control group |
Primary outcome
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary
Time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Mental health for all study participants
Change in Caregiver Burden Scale (CBS)
Time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Caregiver Burden for the family members
2 secondary outcomes
Quality of Life after Traumatic Brain Injury (QOLIBRI)
Time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Faces IV
Time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helene L. Soberg, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Traumatic Brain Injury Family System Intervention. and Psycho-educational session at OUH in people with Traumatic Brain Injury, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Short Form 36 Health Survey (SF-36) Mental Component Summary (time frame: Baseline at study start, at 8 weeks after inclusion, 6 months after completion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.